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Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication

NCT01163435 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2013-12-03

No results posted yet for this study

Summary

Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country.

The aims of this study are:

1. to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;
2. to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy as rescue regimen in H. pylori eradication;
3. to compare the patient adherence and adverse effects of these treatment regimens;
4. to investigate factors that may influence H. pylori eradication by these treatment regimens;
5. to investigate and analyze the prevalence and trend of antibiotic resistance.

Conditions

  • Helicobacter Infection

Interventions

DRUG

high dose dual therapy

rabeprazole 20 mg qid,amoxicillin 750 mg qid for 14 days

DRUG

sequential therapy

rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days

DRUG

clarithromycin-based triple therapy

rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days

DRUG

levofloxacin-based triple therapy

rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Jyh-Chin Yang, M.D.Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163435 on ClinicalTrials.gov